Infections From Unapproved, Contaminated Stem Cell Treatments Lead To FDA Warning
Nearly a dozen people have become ill after receiving tainted and unapproved stem cell cord blood treatments, according to federal regulators.
The U.S. Food and Drug Administration (FDA) issued a warning this week to Genetech, Inc. and Liveyon, LLC., for marketing stem cell treatments that were not properly approved by the agency and appear to pose a serious risk for consumers.
The FDA indicates that the treatments were not prepared according to proper guidelines, causing the stem cells to become contaminated.
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At least 12 reports have been received involving patients from Arizona, Florida, and Texas becoming ill from blood and other infections caused by bacteria, according to the U.S. Center for Disease Control and Prevention (CDC)’s December 21, Morbidity and Mortality Weekly Report.
The patients received the stem cell treatments for a variety of problems including back pain, rotator cuff tear, and rheumatoid arthritis. All patients required hospitalization. The CDC is still trying to determine if other patients received the tainted product.
Genetech processed umbilical cord blood-derived stem cell products which were then distributed by Liveyon. The products were not FDA approved, and inspectors found that the company deviated from good tissue practice and good manufacturing practice requirements after inspecting the Genetech facility in June.
The company was cited for violations that may have allowed the stem cell products to become contaminated with bacteria, potentially causing serious blood infections in patients.
“During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products, including: deficient donor eligibility practices; unvalidated manufacturing processes; uncontrolled environment; lack of control over the components used in production and a lack of defined areas or a control system to prevent contamination and mix-ups,” FDA Commissioner Scott Gottlieb wrote in a press release. “These deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects.”
The products are intended to be administered via injection and for homologous uses only. Homologous uses call for the products to be used for the same function for the recipient and the donor.
Instead, the products were used for allogenic uses, which is when the use is genetically similar, but not the same.
The only FDA approved stem cell use is for hematopoietic reconstitution. This is for people with blood disorders that have difficulty producing blood. Thus, it can be used in blood or bone marrow transplants.
While stem cells are in the development stage for other uses, the products can only be used on humans if the company has an investigational new drug application. However, neither Genetech nor Liveyon had one.
The FDA also issued warnings to 20 other companies that also use stem cell products. The letters emphasize the FDA’s compliance and enforcement policy to companies offering similar stem cell treatments.
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